Clinical Evaluation of the Long‑Term Effects of Contact Lens Care Systems - Full Text View

Sponsored by:	Vistakon
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00813761

Purpose

The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.

Condition	Intervention
Myopia	Device: O2Optix contact lens Device: Proclear contact lens Device: ReNu MultiPlus Multi-Purpose Solution Device: Clear Care

MedlinePlus related topics: Eye Wear

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Further study details as provided by Vistakon:

Primary Outcome Measures:

subjective comfort [ Time Frame: at the following visits: 2 week, 1 month, 3 month, 6 month ] [ Designated as safety issue: No ]
biomicroscopy [ Time Frame: at the following visits: 2 week, 1 month, 3 month, 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: O2Optix contact lens contact lens Device: ReNu MultiPlus Multi-Purpose Solution contact lens care solution
2: Active Comparator Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution	Device: Proclear contact lens contact lens Device: ReNu MultiPlus Multi-Purpose Solution contact lens care solution
3: Active Comparator O2Optix contact lens and Clear Care lens care solution	Device: O2Optix contact lens contact lens Device: Clear Care contact lens care solution
4: Active Comparator Proclear contact lens and Clear Care lens care solution	Device: Proclear contact lens contact lens Device: Clear Care contact lens care solution

Eligibility

Criteria

Inclusion Criteria:

Be at least 18 years old.
Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
Require a visual correction in both eyes (monovision allowed but not monofit).
Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.
Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.
Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.
Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

Requires concurrent ocular medication.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
Worn lenses on an extended wear basis in the last 3 months.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
PMMA or RGP lens wear in the previous 8 weeks.
Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
Abnormal lacrimal secretions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813761

Contacts

Contact: Graeme Young

Sponsors and Collaborators

Vistakon

More Information

Responsible Party:	Vistakon ( Kristy Canavan, Sr. Research Optometrist )
Study ID Numbers:	CR-4522
Study First Received:	December 17, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00813761
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Myopia

ClinicalTrials.gov processed this record on January 13, 2009